[*CONFIDENTIALTREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK[***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGECOMMISSION.]**Exhibit 10.10****Commercial Supply Agreement****-By and Between-****Precision Pharma Services, Inc.****&****Javelin Pharmaceuticals, Inc.****For****Diclofenac Sodium (75mg/2mL) Injection****(DylojectTM Injection)**
 

 
**Table of Contents**       **Section** **Title** **Page**1. DEFINITIONS  2  2. TERM AND TERMINATION OF AGREEMENT  4  3. GENERAL OBLIGATIONS  7  4. OWNERSHIP  9  5. PURCHASE ORDERS AND DELIVERIES  9  6. PURCHASE PRICE AND PAYMENT TERMS  12  7. COVENANTS, WARRANTIES AND REPRESENTATIONS  13  8. QUALITY ASSURANCE, QUALITY CONTROL AND INSPECTIONS  15  9. ADVERSE DRUG EXPERIENCES AND PRODUCT COMPLAINTREPORTS  16  10. CONFIDENTIALITY  17  11. INDEMNIFICATION  18  12. INSURANCE  19  13. DISPUTE RESOLUTION  21  14. RECALL  21  15. NOTICES AND MISCELLANEOUS TERMS  22  **Schedule 1.15** **Product Specifications**  27  **Schedule 1.3** **Javelin Pharmaceuticals Inc., Components**  28  **Schedule 6.1** **Product Description and Purchase Price**  29  **Schedule 6.7** **Itemized Supplemental Service Fees**  30 
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]**COMMERCIAL SUPPLY AGREEMENT**     This Commercial Supply Agreement (this “Agreement”) is entered into this **15****th****dayof February, 2007**, (the “Agreement Date”) by and between **JAVELIN**PHARMACEUTICALS, INC.,(hereinafter referred to as “Javelin”) and PRECISION PHARMA SERVICES, INC., 155 Duryea Road,Melville, New York, 11747 USA (hereinafter referred to as “PPS”) (each individually a “Party” andcollectively, the “Parties”).**WITNESSETH:**     WHEREAS, Javelin desires to engage PPS to manufacture, bulk sterile filter, aseptic fill,inspect, and supply the Javelin product known as **Diclofenac**TM in a **75mg/2mL injection**; and     WHEREAS, PPS possesses the facilities, know-how and skills to accomplish such manufacture,bulk sterile filtering, aseptic filling, inspecting, and supplying desired by Javelin on the termsand subject to the conditions set forth herein.     NOW, THEREFORE, in consideration of the premises, mutual covenants, promises and agreementsset forth herein, and for other good and valuable consideration, the receipt and sufficiency ofwhich are hereby acknowledged, the Parties hereby agree as follows:**1. DEFINITIONS**1.1. “Adverse Drug Experience” shall have the meaning given in 21 C.F.R. § 314.80(a). 1.2. “Affiliate” shall mean with respect to either Party, any Person that directly or indirectlycontrols, is controlled by, or is under common control with, such Party. For purposes of thisdefinition, “control” of another Person shall mean ownership, or direct or indirect control,of at least 50% of the voting stock or other ownership interest of the other Person, or director indirect possession of the power to direct or cause the direction of the management andpolicies of the other Person by any means whatsoever. 1.3. “Annual Minimums” shall have the meaning set forth in Section 5.2. 1.4. “Components” shall mean the direct materials purchased by Javelin or by PPS for theProcessing of Product, including without limitation the following materials: (a) active drugproduct, excipients (b) 2mL glass vial, 13mm rubber stopper, 13mm flip top aluminum seal, and(c) such other materials as specified in Schedule 1.3. 1.5. “Dispute” shall have the meaning set forth in Section 13.1.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACEDWITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]1.6. “Equipment” shall mean the equipment specified in Schedule 1.3 that Javelin has purchasedand delivered to PPS or that PPS has purchased and for which PPS has been reimbursed byJavelin. 1.7. “Event of Force Majeure” shall have the meaning given in Section 15.2. 1.8. “FDA” shall mean the United States Food and Drug Administration. 1.9. “EMEA” shall mean the European Medicines Agency. 1.10. “Firm Purchase Order” shall mean a purchase order submitted to PPS by Javelin and acceptedby PPS in accordance with Section 5.4. 1.11. “Good Manufacturing Practices” shall mean current good manufacturing practices that areapplicable to the Product and the Processing thereof, as defined in 21 C.F.R. Parts 210 and211, as amended from time to time, and regulations governed by the European Union (EU). 1.12. “Invention” shall mean any invention, discovery, process, product or design, and anyimprovements to any of the foregoing, used, conceived, created, developed or reduced topractice as a result of, or arising from or during, the Processing of Product by PPS. 1.13. “Batch Records” shall mean master production and control records for the Product, as definedin 21 C.F.R. § 211.186. 1.14. “NDA” shall mean a New Drug Application or an Abbreviated New Drug Application as defined in21 U.S.C. § 355. 1.15. “MAA” shall mean a Marketing Authorization Application. 1.16. “Monthly Maximum” shall have the meaning set forth in Section 5.3. 1.17. “Person” shall mean an individual, corporation, partnership, limited liability company,trust, business trust, association, joint stock company, joint venture, pool, syndicate, soleproprietorship, incorporated organization, governmental authority or any other form of entity. 1.18. “Process” or “Processing”, as the context requires, shall mean the services provided by PPShereunder, such as bulk drug formulation, sterile filtration, aseptic filling, inspecting andtesting of the Product, in strict conformance with the Process Specifications. 1.19. “Process Specifications” shall mean the critical process parameters for manufacturingProduct as defined in the Batch Record.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]1.20. “Product” shall mean DylojetTM (or other Diclofenac Sodium injectable) manufactured byPPS on behalf of Javelin in conformance with the Process Specifications, Good ManufacturingPractices, and Standard Operating Procedures. 1.21. 1.18 “Product Specifications” shall mean the initial specifications set forth in Schedule 1.15. 1.22. 1.19 “Standard Operating Procedures” shall mean the standard operating procedures established by PPS generally, andfor the Processing of the Product in compliance with Good Manufacturing Practices specifically. 1.23. “Third Party Laboratory” shall have the meaning set forth in Section 3.5. 1.24. “Effective Date” shall mean April 1, 2007.**2. TERM AND TERMINATION OF AGREEMENT**2.1. **Term****.**This Agreement shall commence on the Agreement Date and, unless terminatedearlier pursuant to this Article 2, shall continue for twenty four (24) months (“InitialTerm”) from the Effective Date. Thereafter, this Agreement shall be renewed automatically forsuccessive periods of one (1) year each (each a “Renewal Term”), unless either Party giveswritten notice to the other Party of its intention not to renew this Agreement not less thantwo hundred and seventy (270) days prior to the end of the Initial Term or any Renewal Term.The Initial Term and any Renewal Terms are referred to collectively herein as the “Term”. 2.2. **Termination****.**This Agreement may be terminated as follows: (a) This Agreement may be terminated by either Party if the other Party is inmaterial breach of any provision of this Agreement and such other Party has not curedsuch breach within ninety (90) days of receiving written notice thereof; provided,however, that PPS may terminate this Agreement upon written notice to Javelin in theevent that Javelin fails to make any payment due hereunder within thirty (30) days ofreceiving written notice from PPS that such payment is past due.  (b) This Agreement may be terminated by either Party upon sixty (60) days’ priorwritten notice to the other Party at any time during the Term if the other Party: (i)files in any court pursuant to any statute of any government a petition in bankruptcyor insolvency or for reorganization or for an arrangement or for the appointment of areceiver or trustee of the Party or of its assets; (ii) proposes a written agreementof composition for extension of its debts; (iii) is served with an involuntary petition against it,filed in any insolvency proceeding, and such
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]   petition is not dismissed within sixty (60) days after filing thereof; or (iv)makes an assignment for the benefit of its creditors. (c) This Agreement shall automatically terminate if the Product is permanentlyand completely withdrawn from all markets for serious adverse health or safetyreasons.  (d) PPS Obligations. If after twelve (12) months, or prior to the firstmanufacture of Product by PPS (whichever occurs first), PPS fails to meet itsperformance obligations with regards to the manufacture Product in accordance withcGMP then Javelin may elect to terminate the agreement.2.3. **PPS’s Obligations Upon Expiration or Termination****.**Upon expiration or termination ofthis Agreement for any reason, unless otherwise provided in this Article 2, PPS shall ceaseand refrain from Processing the Product for Javelin and shall perform the actions set forthbelow, provided that such actions may be delayed to the extent necessary for PPS to fulfillany Firm Purchase Orders outstanding as of the date of such expiration or termination. (a) Return to Javelin at Javelin’s request and expense, all confidential andproprietary information or documents supplied by Javelin to PPS and all originaltechnical data and technology provided by Javelin to PPS, and shall make no furtheruse of such confidential or proprietary information except as permitted herein.Notwithstanding the foregoing, PPS may retain for archival purposes one copy of allsuch information; documents, data and technology.  (b) Return to Javelin at Javelin’s expense, all inventory in PPS’s possession ofthe Product and Javelin Components (including, without limitation, allwork-in-progress), excluding such amounts of Product and Javelin Components as arerequired by PPS in order to fulfill all Firm Purchase Orders outstanding as of thedate of such expiration or termination.  (c) Return to Javelin, at Javelin’s expense, all Equipment that is in PPS’spossession as of the date of such expiration or termination.  (d) Reimburse Javelin for all expenses incurred by Javelin relating to the returnto **PPS**of all confidential and proprietary information pursuant to Section 2.4(a).2.4. **Javelin’s Obligations Upon Expiration or Termination****.**Upon expiration or terminationof this Agreement for any reason, unless otherwise provided in this Article 2, Javelin shall:
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] (a) Return to PPS, at PPS’s request and expense, all confidential and proprietaryinformation or documents supplied by PPS to Javelin and all original technical dataand technology provided by PPS to Javelin and shall make no further use of suchconfidential or proprietary information except as permitted herein. Notwithstandingthe foregoing, Javelin may retain for to the extent necessary for legal archivalpurposes only one copy of all such information, documents, data and technology.  (b) Reimburse PPS for all expenses incurred by PPS relating to the return toJavelin of all confidential and proprietary information pursuant to Section 2.3(a),all Product and Javelin Components pursuant to Section 2.3(b) and all Equipmentpursuant to Section 2.3(c).  (c) Pay all outstanding invoices and other accrued payments owed by Javelin toPPS up to and including the date of such expiration or termination (“OutstandingObligations”), and all amounts owed by Javelin pursuant to Section 2.3(c), unless anysuch invoice or other accrued payment is the subject of a good faith dispute betweenthe parties.  (d) If after the Initial Term, except in the case of termination by Javelin forPPS’s uncured material breach, pay to PPS, not as a penalty, an amount equal to (i)the Annual Minimums pursuant to Section 5.2 times (iii) the price per unit set forthin Schedule 6.1 less (iii) money actually paid during the period covered by theunfulfilled Annual Minimum(s)and any Outstanding Obligations.  (e) Notwithstanding anything to the contrary set forth in this Agreement, in theevent that PPS supplies Javelin with Product during the period between the giving ofany notice of termination pursuant to this Article 2 and the effective date of suchtermination, Javelin shall pay for such Product on a COD basis. This paragraph 2.4(f)shall not apply if the Agreement herein is set to expire based upon non-renewal.  (f) Javelin shall purchase within one hundred twenty (120) days after theexpiration or termination of this Agreement PPS’s inventory of Product at the priceper Product set forth on Schedule 6.1.2.5. **No Effect****.**Expiration or termination of this Agreement shall not affect thefollowing: (a) The obligation of Javelin to pay to PPS all outstanding invoices and otheraccrued payments owed to PPS by Javelin hereunder through the date of such expirationor termination, except to the extent that a good faith dispute over such invoicesexists.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] (b) The obligation of each Party otherwise to fulfill all obligations to the otherParty hereunder that arose prior to the date of such expiration or termination.  (c) Any obligation hereunder that expressly survives expiration or termination,including without limitation those set forth in Articles 10, 11, 12, 13 and 14.  (d) The remedies of either Party otherwise available to it at law or in equity inrelation to any rights accrued under this Agreement prior to such expiration ortermination.**3. GENERAL OBLIGATIONS**3.1. **Javelin Responsibility****.**Upon release of Product to Javelin, Javelin is responsiblefor: (i) labeling and packaging of Product; (ii) release of the final Product for sale ordistribution in accordance with all applicably; laws; (iii) any stability testing programrelating to the Product; (iv) retaining and maintaining any samples of the Product at the PPSfacility or elsewhere as may be specified by Javelin; and (v) obtaining the required DrugListing for the Product and providing a copy of Drug Establishment Regulatory Form 2656 to PPSpromptly after the Product is approved for marketing by the FDA and/or EMEA for Europeandistribution. 3.2. **Product Registration****.**Javelin shall be solely responsible for obtaining, maintainingand monitoring the registration of the Product with the FDA and other applicable regulatoryauthorities. PPS shall use commercially reasonable efforts to provide to Javelin suchdocumentation reasonably requested by Javelin relating to PPS’s Processing of Product tosupport Javelin’s submission to the FDA of an NDA and to the EMEA of an MAA for the Product.PPS shall provide such documentation in accordance with timelines agreed to by both Parties.PPS shall use commercially reasonable efforts to cooperate with the FDA or any otherapplicable regulatory authority in the event that such authority requires additionalinformation from PPS relating to PPS’s Processing of Product. Javelin shall be solelyresponsible for all expenses associated with Product-specific validation work. 3.3. **Facility Permits****.**In the event that a regulatory authority imposes any requirementson PPS not in existence as of the Effective Date with respect to permits, licenses orcertifications for any facility where PPS performs Processing, PPS shall bear such expensesnecessary in order for PPS to comply generally with Good Manufacturing Practices, and Javelinshall bear such expenses that are incurred only as a result of PPS’s performance of Processingfor Javelin. 3.4. **Client Components****.**At Javelin’s sole discretion, either Javelin will procure allnecessary Javelin Components and shall send to PPS in amounts and on a schedule as PPS maydirect and that are reasonably correlated to any outstanding purchase orders, or
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]  at Javelin’s direction PPS shall purchase such components and invoice Javelin for allcosts, plus ten percent (10%) mark-up, incurred. If Javelin elects to have PPS procureJavelin Components, PPS shall utilize the same standard of care it uses when purchasingmaterials for itself and will utilize commercially reasonable efforts to obtain the bestterms possible. In the event that Javelin elects or directs PPS to purchase quantities inexcess of what PPS requires pursuant to outstanding purchase orders and desires PPS tostore such components, then the Parties will negotiate reasonable terms to cover PPS’s costof storage and other related expenses.3.5. **Javelin Testing****.**PPS shall test and inspect each lot of Product for conformance withthe Product Specifications applicable thereto prior to shipment of such Product to Javelin.After receipt thereof, Javelin shall test and inspect each lot for conformance with theProduct Specifications, (including all product documentation), using test methods described inthe Product Specifications. If within sixty (60) days after receipt of any lot of Product byJavelin, Javelin notifies PPS in writing that such lot does not conform to the ProductSpecifications and Process Specifications have been met, Javelin shall pay PPS the per vialprice set forth in Schedule 6.1. If within sixty (60) days after receipt of any lot of Productby Javelin**,**Javelin notifies PPS in writing that such lot does not conform to the ProductSpecifications as a result of deviation from the Process Specifications and as determined byJavelin’s testing and inspection of such Product, PPS shall retain the per vial price setforth in Schedule 6.1 and manufacture a replacement batch at PPS’s expense within ninety (90)days after PPS’s confirmation that such Product is non-conforming. PPS shall have thirty (30)days to determine such confirmation or refer the matter to [***] (“**Third Party Laboratory**”).PPS reserves the right to have each lot of Product tested by the Third Party Laboratory if theParties disagree as to whether the Product is non-conforming. If the Third Party Laboratorydetermines that the Product does meet Product Specifications, then the cost of such testingshall be borne by Javelin, otherwise costs to be borne by PPS. The determination of the Third PartyLaboratory with respect to Product conformance shall be final and binding on both parties.In the event that Product does not conform to Product Specifications as a result ofdeviation from the Process Specifications, PPS shall deliver replacement Product to Javelinat PPS’s expense. Javelin shall, at PPS’s option, direction, and expense, either (a) returnnon-conforming Product to PPS or (b) destroy non-conforming Product in accordance with allapplicable laws and regulations. Javelin shall be deemed to have accepted each lot ofProduct with respect to which it does not notify PPS in writing of any non-conformitywithin sixty (60) days after its receipt thereof. Upon agreement by PPS, or determinationby Third Party Laboratory, that a Product is non-conforming, Javelin and PPS shall conducta good faith investigation into the reasons for such non-conformance. PPS shall makecommercially reasonable efforts to provide Javelin, and/or its designee(s), with access tothe facility in which the Product was manufactured, all
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]  manufacturing equipment, and all relevant documentation and records, to determinewhether there has been a deviation from the Process Specifications.**4. OWNERSHIP**4.1. **Ownership of Product****.**Except as otherwise provided herein, Javelin shall own allright, title and interest in and to the Product, including without limitation all patent,copyright, trademark, trade secret and other proprietary rights therein. Javelin hereby grantsto PPS, and PPS hereby accepts, a non-exclusive, worldwide, royalty-free license to use orpractice, as applicable, such patent, copyright, trademark, trade secret and other proprietaryrights of Javelin as necessary to fulfill PPS’s obligations under this Agreement. 4.2. **Javelin’s Trademarks****.**PPS acknowledges and agrees that the trademarks, trade names,trade dress, labels, labeling and designs used or to be selected by Javelin for use inconnection with the Product are the property of Javelin and that PPS shall have no rights inor to such trademarks, trade names, trade dress, labels, labeling or designs except asnecessary to fulfill its obligations hereunder. 4.3. **Ownership of Inventions****.**PPS shall own all right, title and interest in and toinventions, including without limitation all patent, copyright, trademark, trade secret andother proprietary rights therein that arise as a result of ideas developed or work performedby PPS during this contract. Javelin shall own all right, title and interest in and toInventions, including without limitation all patent, copyright, trademark, trade secret andother proprietary rights therein that arise as a result of work specifically requested by, or at the direction of, Javelin during thiscontract. 4.4. **PPS’s Trademarks****.**Javelin acknowledges and agrees that trademarks and trade namesused by PPS are the property of PPS and that Javelin shall have no rights in or to suchtrademarks or trade names.**5. PURCHASE ORDERS AND DELIVERIES**5.1. **Forecast****.**Unless otherwise agreed to by the Parties, not less than six (6) calendarmonths prior to the initial shipment date for the first order of Product hereunder, Javelinshall submit to PPS a forecast of the batch quantities of Product that Javelin expects toorder for delivery during the twelve (12) months following such initial shipment date.Thereafter, no later than thirty (30) days before the start of each subsequent calendar month,Javelin shall submit to PPS a twelve (12) month revised forecast estimating the quantity ofProduct that Javelin expects to order for delivery during the following twelve
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]  (12) month period. The twelve (12) month rolling forecasts provided for in thisSection 5.1 of which the first six (6) months of any rolling forecast will be binding andpurchase orders will be issued for each month of the binding forecast and the remaining six(6) months shall not be binding and will be used by PPS for planning purposes only. 5.2. **Minimum Quantities****.**During the first twenty four (24) months following the EffectiveDate, Javelin shall place firm orders for [***] (“**Annual Minimums**”) to be manufactured anddelivered during such periods on a take or pay basis. In the event that Javelin does not orderduring any twelve month period the applicable Annual Minimum, then it shall be obligated topay PPS within thirty (30) days the difference in amounts actually paid during that period andwhat would have been paid had the Annual Minimum commitment been met. 5.3. **Monthly Maximum****.**During the Term, after the date that the FDA or EMEA approves theNDA or the MAA for the Product, Javelin’s requirements for the Product that it orders from PPSshall be [***] units of Product per month (“**Monthly Maximum**”). In the event that Javelinanticipates the need for more than this maximum amount, PPS shall use commercially reasonableefforts to increase its capacity to meet such excess demand. 5.4. **Annual Minimum Product Manufacturing Capacity****.**PPS guarantees to Javelin that PPSwill have capacity during each Product contract year to fill orders for the manufacture anddelivery equal to the Annual Minimum quantity pursuant to Section 5.2. In the event Javelin anticipates that it will require Product in excess ofthe Annual Minimum Manufacturing Capacity during any Product contract year, it shall sonotify PPS as it so determines. 5.5. **Receipt of Purchase Order****.**PPS’s obligation to Process and supply any specificquantity of Product shall be contingent upon the submission by Javelin and acceptance by PPS,of a written purchase order in accordance with the terms of this Article 5. Each purchaseorder submitted by Javelin shall set forth the quantity of Product to be purchased, thedelivery and shipping instructions and delivery schedule thereof. Unless PPS’s prior writtenapproval states otherwise, Javelin shall use commercially reasonable efforts to allocate itsannual purchases evenly over each month and in no case shall any one month order exceed theMonthly Maximum. 5.6. **Purchase Order Acceptance****.**Purchase orders placed with PPS by Javelin may beaccepted by PPS for each month of production and will be reviewed by PPS within fourteen (14)days after PPS’s receipt. PPS shall make commercially reasonable efforts to supply Javelinwith Product as requested in a purchase order. Each purchase order shall become a firm orderand binding on PPS only upon acceptance by PPS of such purchase order in accordance with theterms of this Section 5.4 (each such accepted purchase order
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]  a “**Firm Purchase Order**”). If PPS does not reject a purchase order within the fourteen(14) day period after receipt, the order shall be considered to be accepted. PPS will bedeemed to have satisfied each Firm Purchase Order if the quantity of Product supplied isnot more than 110% and not less than 90% of the quantity ordered by Javelin. In the eventof any conflict between the terms and conditions of this Agreement and the terms andconditions of any Firm Purchase Order, the terms and conditions of this Agreement shallcontrol. 5.7. **Lead Time****.**Each Firm Purchase Order shall require a shipment date for the firstshipment of Product there under not less than one hundred and eighty (180) days from the dateof such Firm Purchase Order. Delivery dates set forth in Firm Purchase Orders will be deemedto be estimated dates only. 5.8. **Delivery****.**Javelin shall arrange for delivery of Product to Javelin from PPS’sMelville plant in accordance with the instructions in the relevant Firm Purchase Order. EachFirm Purchase Order shall designate one single delivery location within the continental UnitedStates. At Javelin’s request, PPS shall include on packaging slips for the Product the FirmPurchase Order number or other identifying number specified by Javelin. All deliveries shallbe EXW (PPS’s Melville plant) (Incoterms 2000). Javelin shall be solely responsible for allshipping costs, including without limitation all freight, insurance charges, taxes, importand export duties, inspection fees and other charges applicable to the sale and transportof Product supplied by PPS hereunder. Javelin shall comply with all export laws,restrictions and regulations of any U.S. or foreign agency or authority, and shall notexport or re-export the Product, or any materials or technology derived from the Product,in violation of any such laws, restrictions, or regulations, or without all necessaryapprovals. Without limiting the generality of the foregoing, Javelin shall not export orre-export the Product, or any materials or technology derived from the Product, to anyproscribed country, party or entity listed in the applicable laws, regulations and rules ofthe U.S. government unless properly authorized. 5.9. **Changes to Firm Purchase Orders****.**Except as otherwise expressly provided in thisAgreement, there shall be no modification or cancellation of any Firm Purchase Order except bymutual written agreement of the Parties; provided, however, that in the event that PPS acceptsa purchase order from Javelin for an aggregate amount of Product to be shipped in any monththat exceeds by one (1) batch or one-hundred percent (100%) or more the amount specified inthe most recent forecast covering such month provided pursuant to Section 5.1, there shall bea commercially reasonable extension of the time periods for delivery of such Product by PPS,if requested by PPS.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]**6. PURCHASE PRICE AND PAYMENT TERMS**6.1. **Purchase Price****.**In consideration of the Processing to be performed by PPS hereunder,Javelin shall pay to PPS the price per Product as set forth on Schedule 6.1, subject toescalation as provided in Section 6.2. Javelin shall pay such price for all Product deliveredhereunder (e.g., for samples of Product as well as for Product destined for commercial sale). 6.2. **Price Escalator Formula****.**The Product prices set forth on Schedule 6.1 hereto shallbe adjusted at the start of the first Renewal Term following the Effective Date, and on eachsubsequent January 1st thereafter during a Renewal Term to reflect the percentageincrease in the inflation rate for the [***] period ending on December 31st, as measured bythe Consumer Price Index (CPI for Pharmaceutical Products) issued by the Bureau of LaborStatistics, U.S. Department of Labor. 6.3. **Product Specification or Process Specification Changes****.**In the event that theParties agree to modify the Product Specifications or Process Specifications, PPSshall advise Javelin as to any proposed price adjustments that would result from suchmodification. The Parties shall negotiate in good faith to reach agreement on the adjustedprice for PPS’s supply of the Product based on such modified Product Specifications orProcess Specifications, giving due consideration to the effect of such modification, onPPS’s costs in performing Processing. Notwithstanding anything to the contrary set forth inthis Agreement, PPS shall have no obligation to supply Products based on modified ProductSpecifications or Process Specifications if the Parties do not agree on a mutuallyacceptable price adjustment. 6.4. **Invoices****.**PPS shall send all invoices to a single address specified in writing bythe Javelin. All invoices to Javelin shall be stated and payable in United States dollars andshall indicate the quantity of Product shipped to Javelin pursuant to Firm Purchase Ordersduring the period stated on such invoice, and the price for the Product covered by suchinvoice. 6.5. **Remittance****.**Javelin shall pay all amounts stated in each invoice to PPS withinthirty (30) days of the date of such invoice, without any offset or deduction of any naturewhatsoever. In the event that Javelin fails to pay all or any part of any invoice on the duedate thereof, and PPS elects not to terminate Agreement pursuant to Section 2.2 (a), Javelinshall pay interest on the unpaid amount at an annual rate equal to 1.5% above the lowest primerate as published in The Wall Street Journal on or nearest to such due date, whichinterest will accrue from such due date through the date such unpaid amount is paid in full.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]6.6. **Taxes****.**Javelin shall be solely responsible for paying all taxes, levies, dutiesor fees of any kind, nature or description whatsoever (except for taxes based on PPS’s netincome or gross receipts) applicable to the Processing or transportation of Product hereunder. 6.7. **Supplemental Costs****.**Costs for supplemental services, as requested by Javelin and tothe extent reasonably available from PPS, to be paid by Javelin are shown in Schedule 6.7.These services may include, documentation, validation, Quality/Compliance, Engineering andAnalytical services. PPS shall invoice Javelin monthly for such services, and payment shall bedue net thirty (30) days after the date of invoice and otherwise as set forth in Section 6.5.**7. COVENANTS, WARRANTIES AND REPRESENTATIONS**7.1. **PPS Covenants and Warranties****.** (a) **GMPs and SOPs****.**PPS covenants and warrants that the Product purchasedby Javelin hereunder shall be Processed in all material respects in accordance withGood Manufacturing Practices, Standard Operating Procedures, and the terms andconditions of this Agreement.  (b) **Adulteration and Misbranding****.**PPS covenants and warrants that as ofthe time that Products are made available to Javelin, such Products will not beadulterated or misbranded, and will not be articles that could not, under theprovisions of the Federal Food, Drug and Cosmetic Act, be introduced into interstatecommerce, or under the provisions of the European Union be introduced into commerce inthe EU. For purposes of this Section 7.1(b), “adulterated” shall have the meaninggiven in 21 U.S.C. § 351, and “misbranded” shall have the meaning given in 21 U.S.C. §352. The covenant and warranty set forth in this Section 7.1(b) shall not apply ifsuch adulteration, misbranding, or inability to be introduced into interstate commerceresults from the use of Javelin Components.  (c) **Deviations from Product Specifications****.**PPS warrants that there willbe no deviations from the Product Specifications as a result of PPS’s negligence.7.2. **Javelin Pharmaceuticals Inc. Covenants and Warranties****.** (a) **Client Components****.**If PPS procures Components, PPS shall test andrelease all Components used in the manufacture of Javelin’s product in accordance withGood Manufacturing Practices. In the event that Javelin supplies and tests components,Javelin covenants and warrants that any Components supplied to
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]   PPS by Javelin shall be manufactured in accordance with Good ManufacturingPractices and the terms and conditions of this Agreement.  (b) **Use of Products****.**Javelin covenants and warrants that it shall hold,store, handle, ship, deliver, distribute and sell the Products in accordance with GoodManufacturing Practices and all other applicable laws.  (c) **No Claims****.**Javelin covenants and warrants that there are no adverseactions, suits or claims pending or threatened against it or any of its Affiliateswith respect to the Product.7.3. **Mutual Representations and Warranties****.**In addition to the other representations andwarranties set forth in this Article 7, each Party represents and warrants to the other Partythat: (a) **Authorization****.**The execution, delivery and performance of thisAgreement by such Party have been duly authorized by all necessary action on the partof such Party; and  (b) **Enforceability****.**This Agreement, when executed and delivered by suchParty in accordance with the provisions hereof, will be a legal, valid and bindingobligation of such Party, enforceable against such Party in accordance with its terms,except as such enforceability may be limited by applicable bankruptcy, insolvency,moratorium, reorganization or similar laws affecting the enforcement of creditors’rights generally and by limitations on the availability of specific performance andother equitable remedies against such Party; and  (c) **No Conflicts****.**Such Party’s execution, delivery and performance ofthis Agreement shall not constitute a violation, breach or default under any contract,instrument, obligation or agreement to which it is a party or by which it is bound andwill not conflict with or violate any applicable law, rule, regulation, judgment,order or decree of any governmental agency or court having jurisdiction over it or itsassets or property.7.4. **NO OTHER WARRANTIES****. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS ARTICLE 7, PPSMAKES NO WARRANTY OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, AND ALL IMPLIED WARRANTIES, INCLUDINGWITHOUT LIMITATION THE WARRANTY OF FITNESS FOR A PARTICULAR USE OR PURPOSE AND THE WARRANTY OFMERCHANTABILITY, ARE HEREBY DISCLAIMED BY PPS.**
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]**8. QUALITY ASSURANCE, QUALITY CONTROL AND INSPECTIONS**8.1. **Batch Records****.**PPS shall include with each batch of Product delivered to Javelin acomplete copy of the applicable executed Batch Records including all testing results,associated processing charts, printouts and certificates of analysis (which shall have beenreviewed and approved by PPS’s internal quality assurance department) relating to PPS’sProcessing of such Product. Javelin shall review and approve such Batch Records within sixty(60) calendar days.8.2. **Deviations****.**PPS shall document in writing any deviation from Standard OperatingProcedures or the Product Specifications by means of a deviation report, which report shall beattached to the Batch Records to which the report applies. PPS shall maintain a validationprogram consistent with Good Manufacturing Practices. All investigations, OOSs, CAPAs, andenvironmental excursions that may have an impact on any batch of Product or its componentsmust be included with the batch documentation, and must be provided in accordance with theterms of the Quality Agreement.8.3. **Quality Control****.**PPS shall perform such quality assurance testing as it deemsnecessary to maintain a quality control program consistent with Good Manufacturing Practices.8.4. **Loss of Product****.**Subject to PPS’s Limitation of Liability, any loss of Product orJavelin Components during Processing that exceeds allowed production losses (as defined in theStandard Operating Procedures and Batch Records) and that is not attributable to contingenciesbeyond PPS’s reasonable control shall be for the account of and charged to PPS at a cost, inrespect of each batch of Product or Javelin Components, of [***], whichever is less. ForProduct loss attributable to PPS not resulting from activities performed in the normal courseof Processing of Product, PPS shall be liable for [***] subject to PPS’s annual limitation ofliability.8.5. **Audits****.**Up to one time per month Javelin may choose to observe, or have its designeeobserve, the manufacturing, inspection, testing or other related processing of a batch ofJavelin’s Product upon two (2) weeks communicated notice. Additional visits as required shallbe accepted by PPS for documentation and testing issues that affect any batch towards itsrelease. One time per year during each calendar year of the Term, Javelin shall have theright, at its sole expense, upon not less than four (4) weeks’ prior written notice to PPS, toinspect or audit, or have its designee inspect or audit, with its QP present, during normalbusiness hours those sections of PPS’s facilities used directly in, and documents relatingdirectly to PPS’s Processing of Product for Javelin (including all applicable PPS SOP’s), forthe purpose of monitoring PPS’s compliance with the previsions of this Agreement.Notwithstanding the foregoing, PPS reserves the right to deny Javelin access to any facilitywhere there is a risk to health or safety or to the
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]  security or quality of Products being Processed hereunder or any other products beingprocessed by PPS, provided that PPS shall provide access to such facility as soon aspractical. 8.6. **Governmental Inspection****.**In the event any relevant regulatory authority notifies PPSof its intention to inspect PPS’s facilities specifically in connection with anythingassociated with the manufacturing, testing, processing or otherwise, that may affect theJavelin Product, PPS shall notify Javelin of such inspection immediately and shall supplyJavelin with copies of all relevant correspondence relating to such inspection. Javelin maysend representatives to such PPS facilities to participate in any such inspection at Javelin’sexpense. In the event PPS receives any communication from any relevant regulatory authority inconnection with PPS’s Processing of Product for Javelin hereunder that requires a response oraction by PPS, including, but not limited to, an FDA Form 483 (Inspectional Observations) or aWarning Letter, PPS shall notify Javelin immediately, Javelin shall cooperate fully with PPSin connection with PPS’s preparation of such response, and promptly shall provide PPS with alldata or other information required by PPS in preparing such response.**9. ADVERSE DRUG EXPERIENCES AND PRODUCT COMPLAINT REPORTS**9.1. **Adverse Drug Experiences****.**Javelin shall be responsible for reporting to the FDAand/or the MHRA, as required by applicable law, all Adverse Drug Experiences associated withthe Product. Within the period of time prescribed by applicable law after PPS becomes aware ofan Adverse Drug Experience, PPS shall notify Javelin of such Adverse Drug Experience.9.2. **Complaints****.**If Javelin receives any complaint associated with PPS’s Processing ofProduct or PPS’s use of any Javelin Component, including without limitation a complaint fromthe FDA’s MedWatch service, Javelin shall immediately notify PPS of such complaint bytelephone, and PPS shall provide a preliminary response in writing to Javelin regarding thecomplaint within twenty four (24) hours after receiving the notification by Javelin, Javelinshall have sole responsibility for responding to complaints associated with the Product orJavelin Components, whether such complaints are received by Javelin or by PPS. Javelin shallprovide a written response on each complaint to each complainant, and shall providesimultaneously a copy of such response to PPS.9.3. **Complaint Files****.**Javelin and PPS, as applicable, shall maintain complaint files inaccordance with Good Manufacturing Practices.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]**10. CONFIDENTIALITY**10.1. **Confidentiality Obligation****.**During the Term and for a period of five (5) yearsfollowing the expiration or termination hereof, each Party (the “Recipient”) shall maintain inconfidence all information and materials disclosed by the other Party (the “Disclosing Party”)and marked as confidential or which the Recipient knows are or contain trade secrets or otherproprietary information of the Disclosing Party including, without limitation, informationrelating to the Processing of Product or the business plans of the Disclosing Party andinformation provided by the Disclosing Party to the Recipient prior to the Effective Date(collectively, “Confidential Information”). The Recipient shall not use the Disclosing Party’sConfidential Information for any purpose except as permitted by this Agreement, or disclosethe same to anyone other than those of its Affiliates, directors, officers, employees, agents,subcontractors, consultants or counsel as are necessary in connection with such Party’sactivities as provided in this Agreement or whose duties require access to such ConfidentialInformation. The Recipient shall obtain a written agreement from any directors, officers,employees, agents, subcontractors, consultants and counsel prior to disclosure of theDisclosing Party’s Confidential Information (unless such party is otherwise under a duty ofconfidentiality to Recipient), to hold in confidence and not make use of such ConfidentialInformation for any purposes other than those permitted by this Agreement.10.2. **Exceptions to Confidentiality Obligations****.**The obligation of confidentialitycontained in this Agreement shall not apply to the extent that the Recipient can demonstratethat (i) the disclosed information was at the time of such disclosure to the Recipient alreadyin the public domain other than as a result of actions or inactions of the Recipient, itsAffiliates or their respective, directors, officers, employees, agents, subcontractors,consultants or counsel in violation hereof, (ii) the disclosed information subsequently entersthe public domain other than as a result of actions or inactions of the Recipient, itsAffiliates or their respective, directors, officers, employees, agents, subcontractors,consultants or counsel in violation hereof, (iii) the disclosed information was rightfullyknown by the Recipient or its Affiliates (as shown by its written records) prior to the dateof disclosure to the Recipient, (iv) the disclosed information was lawfully received by theRecipient or its Affiliates on an unrestricted basis from a source unrelated to any Party tothis Agreement and not known by the Recipient to be under a duty of confidentiality to theDisclosing Party, or (v) disclosure is required by a government regulatory agency as part ofsuch agency’s product license approval process, or is otherwise required by law, order orregulation of a governmental agency or a court of competent jurisdiction, provided, however,the Recipient shall not make any such disclosure without first notifying the Disclosing Partyand allowing the Disclosing Party a reasonable opportunity to seek injunctive relief from (ora protective order with respect to) the obligation to make such disclosure.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]**11. INDEMNIFICATION**11.1. **PPS’s Indemnification****.**Subject to the PPS’s limitation of liability, PPS shallindemnify, defend and hold Javelin and its Affiliates, and their respective shareholders,directors, officers, employees, agents, successors and assigns harmless from and against anyand all liability, loss, damages and expenses (including without limitation court costs andreasonable attorneys’ fees) suffered as the result of claims, demands, costs or judgments madeor brought against Javelin to the extent such claims arise out of or are caused by PPS’snegligence or misconduct in the Processing of Product.11.2. **Javelin’s Indemnification****.**Javelin shall indemnify, defend and hold PPS and itsAffiliates, and their respective shareholders, directors, officers, employees, agents,successors and assigns harmless from and against any and all liability, loss, damages andexpenses (including without limitation court costs and reasonable attorneys’ fees) suffered asthe result of claims, demands, costs or judgments made or brought against PPS arising out ofor caused by (i) PPS’s Processing of the Product in accordance with Product Specifications,including without limitation any claim that PPS’s Processing of the Product infringes ormisappropriates a third party’s patent, copyright, trade secret, trademark or otherproprietary right, (ii) any negligent act or omission of Javelin in connection with itsperformance under this Agreement, (iii) the use of any Product supplied hereunder or of anyJavelin Component in humans, or (iv) the shipment, storage, or any other use of the Productafter delivery thereof to Javelin’s designated carrier, except in each case to the extent suchclaims, demands, costs or judgments are caused by the misconduct or negligence of PPS or anyof its Affiliates, or their respective agents or employees.11.3. **Indemnification Procedure****.**The indemnifying Party shall have the right to controlany litigation and settlement discussions within the scope of the indemnities provided for inthis Article 11; provided, however, that the indemnifying Party shall not, without obtainingthe prior written consent of the indemnified Party, settle any litigation if such settlementwould impose an admission, obligation or liability on the indemnified Party. The indemnifiedParty shall have the right to select and retain counsel, at the indemnified Party’s ownexpense, to represent such Party in any litigation and settlement discussions. The indemnitiesset forth in this Article 11 shall be inapplicable if the indemnifying Party is not notifiedpromptly of the claim for indemnification and is prejudiced by the delay in notice. Allindemnified Parties shall cooperate to the extent necessary in the defense of any claim withinthe scope of the indemnities provided for in this Article 11. An indemnifying Party’sassumption of the defense or disposition of any matter hereunder may be undertaken withoutprejudice to its right to assert that it is not obligated to indemnify the indemnified Partypursuant to the terms hereof.
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]11.4. **LIABILITY LIMITATION****. PPS’S TOTAL AGGREGATE LIABILITY TO JAVELIN UNDER THISAGREEMENT SHALL NOT EXCEED [***] PER YEAR DURING EACH YEAR OF THE TERM. IN NO EVENT SHALL PPSBE LIABLE FOR LOSS OF PROFITS, LOSS OF GOODWILL OR ANY PUNITIVE, EXEMPLARY, SPECIAL,CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES OF ANY KIND, WHETHER IN CONTRACT, WARRANTY,NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, AND REGARDLESS OF WHETHER PPS HAS BEENADVISED OF THE POSSIBILITY OF SUCH DAMAGES.**11.5. **Survival****.**The obligations of this Article 11 shall survive the expiration ortermination of this Agreement.**12. INSURANCE**12.1. (a) During the Term, and for a period of one year after the expiration of the final batch ofProduct made under this Agreement, PPS shall obtain and maintain the following insurance: i Commercial General Liability insurance, with limits (includingumbrella coverages) of not less than [***] per occurrence for bodily injury andproperty damage liability and [***] in the aggregate. In addition, suchinsurance shall include contractual liability and completed operations. Javelinshall be named as an additional insured under this insurance, but only asrespects PPS’s obligations under this Agreement.  ii Product Liability insurance with limits of not less than [***]per occurance for bodily injury and property damage and [***] in the aggregate.Javelin shall be names as an additional insured under this insurance, but onlyas respects PPS’s obligations under this Agreement.  iii Worker’s Compensation insurance as required under applicablestate law, and employer’s liability insurance with a limit of not less than[***].  iv Any insurance required under applicable US law. (b) With respect to all insurance coverages under Section 12.1(a), and allinsurance carriers shall have a Best’s rating of A:XII or higher. All insurancepolicies shall be occurrence form, except for Products Liability insurance, which isunder a claims made form. Notwithstanding the one-year period specified in Section
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]   12.1(a), PPS shall carry Products Liability insurance for a minimum of five yearsafter the termination or expiration of this Agreement.  (c) PPS shall furnish Javelin with certificates of insurance evidencing the aboverequirements as soon as practicable after the Effective Date and each anniversary ofthe Effective Date during the Term, and all policies will include provisions for atleast thirty (30) days’ written notice of any material change or cancellation.12.2. (a) During the Term, for a period of one year after the expiration of the final batch ofProduct made under this Agreement, Javelin shall obtain and maintain the following insurance: i Commercial General Liability insurance, with limits (includingumbrella coverages) of not less than [***] combined single limit per occurrencefor bodily injury and property damage liability and [***] in the aggregate. Inaddition, such insurance shall include contractual liability and completedoperations. PPS and Talecris Biotherapeutics Holdings Corp. shall be named asan additional insured under this insurance, but only as respects Javelin’sobligations under this Agreement.  ii Product Liability insurance with limits of not less than [***]per occurance for bodily injury and property damage and [***] in the aggregate.PPS and Talecris Biotherapeutics Holdings Corp shall be named as additionalinsured under this insurance but only as respects Javelin’s obligations underthis Agreement.  iii Worker’s Compensation insurance as required under applicablestate law, and employer’s liability insurance with a limit of not less than[***].  iv Any insurance required under applicable US law. (b) With respect to all insurance coverages under Section 12.2(a), all insuranceshall be primary or with a self-insured retention approved by Talecris Risk Managementin advance, and all insurance carriers shall have a Best’s rating of A:XII or higher.All insurance policies shall be occurrence form, except for Products Liabilityinsurance, which is under a claims made form. Notwithstanding the one-year periodspecified in Section 12.2(a), Javelin shall carry Products Liability insurance for aminimum of five years after the termination or expiration of this Agreement.  (c) Javelin shall furnish PPS with certificates of insurance evidencing the aboverequirements as soon as practicable after the Effective Date and each anniversary
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] **** of the Effective Date during the Term, and all policies will include provisions forat least thirty (30) days’ written notice of any material change or cancellation.**13. DISPUTE RESOLUTION**13.1. **Amicable Resolution****.**Prior to either Party filing any court action in connectionwith any dispute, controversy or disagreement (each, a “Dispute”) arising between the Partiesin connection with this Agreement, the Parties shall attempt to resolve such Dispute amicablyin accordance with the terms of this Article 13. As requested by either Party upon theoccurrence of a Dispute, designated representatives of the Parties shall meet and attempt toresolve such Dispute. If the Dispute is not resolved by the mutual agreement of suchdesignated representatives within fifteen (15) days after their first meeting to attempt toresolve the Dispute, then the Dispute shall be referred to the respective senior management ofthe Parties. If such senior managers have not resolved such Dispute within thirty (30) daysafter the date that such Dispute was referred to them, then the Parties shall in good faithconsider binding arbitration after which they shall be free to pursue all remedies availableto them at law or in equity.13.2. **Arbitration****.**If referred to arbitration pursuant to paragraph 13.1 above, thearbitration shall be administered by the American Arbitration Association before three (3)arbitrators in accordance with its Commercial Arbitration Rules. Judgment on the award, ifany, rendered by the arbitrator may be entered in any court having appropriate jurisdiction.The Arbitration shall be binding and shall take place in New York City at the offices of theAmerican Arbitration Association or at such other location as mutually agreed by the parties.13.3. **Provisional Remedies****.**Nothing in this Article 13 is intended or shall be deemed toprevent either Party from seeking injunctive relief (or any other provisional remedy) from anycourt having jurisdiction over the Parties and the subject matter of the dispute as necessaryto protect such Party’s name, confidential or proprietary information, trade secrets, or anyother proprietary rights. Nothing in this Article 13 is intended or shall be deemed to modifythe provisions of paragraph 3.5 (Javelin Testing) and the provisions of that paragraph 3.5shall apply solely in all disputes falling thereunder.**14. RECALL**14.1. **Costs and Expenses****.**Javelin shall immediately notify PPS in writing of any fieldcorrection, injunction, stop sale order, governmental action or directive, or recall regardingthe Product. Javelin shall be solely responsible for implementing and carrying out any suchfield correction, injunction, stop sale order, governmental action or
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[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCHPORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]  directive, or recall, and for complying with all applicable laws relating thereto. Any andall costs and expenses resulting there from, including without limitation reasonable fees ofany experts or attorneys that may be used by either Party, shall be the responsibility ofJavelin; provided, however, that to the extent that such costs and expenses result at leastsubstantially from PPS’s breach of this Agreement, gross negligence or willful misconduct,subject to PPS’s limitation of liability, PPS shall reimburse Javelin for the costs andexpenses proportionately attributable to such breach by PPS, including the costs of anyProduct affected thereby and including the costs of any Javelin Components affected thereby. 14.2. **Survival****.**The obligations of this Article 14 shall survive the expiration orterminationof this Agreement.**15. NOTICES AND MISCELLANEOUS TERMS**15.1. **Notices****.**In any case where any notice or other communication is required orpermitted to be given under this Agreement, such notice or communication shall be in writingand shall be deemed to have been duty given and delivered (a) if delivered in person, on thedate of such delivery, (b) if sent by confirmed facsimile transmission (with answer backreceived), on the date of such facsimile transmission, or (c) if sent by overnight express orregistered or certified mail (with return receipt requested), on the date of receipt of suchmail, and shall be sent to the following address (or such other address as such Party maydesignate from time to time in writing):If to Javelin:Javelin Pharmaceuticals, Inc.